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Given Imaging Announces Data Presented at American College of Gastroenterology Annual Meeting
First U.S. PillCam(TM) COLON Study Results Revealed
| Source: Given Imaging
YOQNEAM, ISRAEL -- (MARKET WIRE) -- October 23, 2006 -- Given Imaging Ltd. (NASDAQ : GIVN ) today
announced highlights of clinical data presented on PillCam™ Capsule
Endoscopy at the Annual Scientific Meeting of the American College of
Gastroenterology which takes place in Las Vegas, Nevada from October 20 to
25. Noteworthy presentations include data from the first U.S. trial
studying PillCam™ COLON as well as a study validating a new index to
measure small bowel mucosal activity.
PillCam™ COLON
"Capsule Colonoscopy - An Interim Report of a Pilot Three Arm, Blinded
Trial of Capsule Colonoscopy, Virtual Colonoscopy and Colonoscopy" -
(Poster #784) Press Conference - Monday, October 23rd, 2006 at 12:30pm PDT
Led by Blair Lewis, M.D., Mount Sinai Medical Center, Douglas Rex, M.D.,
Indiana University Hospital, and David Lieberman, M.D., Oregon Health and
Science University, the study evaluated 25 patients over the age of 50 who
had not had a colonoscopy within the past five years or a family history of
colon cancer. The patients underwent PillCam COLON followed by virtual
colonoscopy and standard colonoscopy three weeks later. Investigators were
blinded to the results. Of the 25 patients, 44% (n=11) had significant
findings defined as at least one polyp measuring 6 mm or more than three
polyps of any size, confirmed by standard colonoscopy (blinded or
unblinded). PillCam COLON identified 64% or (n=7) of the significant
polyps, virtual colonoscopy identified 55% (n=6) and blinded standard
colonoscopy 82% (n=9). The investigators concluded that PillCam COLON is a
promising new technology for visualizing the colon for polyps.
"PillCam COLON in Comparison with Standard Colonoscopy in the Detection of
Polyps-Results from the First Prospective Multi-Center Study" -
(Presentation #52) Press Conference - Monday, October 23rd, 2006 at 12:30pm
PDT; Podium Presentation - Wednesday, October 25th at 8:30am PDT
A total of 91 individuals were enrolled in three Israeli centers, Rambam
Medical Center, Hillel-Yaffe Medical Center and Bikur Holim Hospital; the
results were evaluable in 84 cases. The patients all underwent capsule
colonoscopy with the PillCam COLON and were all scheduled for traditional
colonoscopies later in the day. Polyps of any size were found in 45
patients by either of the screening methods. PillCam COLON identified 76%
(n=34) compared to 80% (n=36) by colonoscopy. Out of the 84 patients,
approximately 24% (n=20) had significant findings, defined as at least one
polyp measuring 6 mm or three or more polyps of any size. Of these,
PillCam COLON identified 14 (70%) and colonoscopy 16 (80%). There were no
adverse events reported except in one patient who had severe abdominal pain
immediately following traditional colonoscopy. The colonic preparation was
well tolerated in all cases.
The initial 44 subjects enrolled in the study received a single oral
"booster" dose of sodium phosphate. The PillCam COLON capsule was excreted
within 10 hours in 70% of the patients and reached various parts of colon
in the other 30%. An additional dose of oral sodium phosphate was added to
the regimen of the final 46 subjects to improve the capsule excretion rate.
The PillCam COLON capsule in these patients was excreted within 10 hours in
78% of the patients and reached the rectosigmoid colon in the other 22%.
Study investigators concluded that further improvements in the procedure
will probably increase capsule examination completion and polyp detection
rates.
PillCam™ SB
Capsule Endoscopy in Patients with Known IBD: Frequency of Findings, and
Influence on Medical and Surgical Management are based on the indication
for CE" (Poster #1085) - Tuesday, October 24th 12:15pm - 2:15pm PDT
Researchers at Mount Sinai Medical Center led by Stephanie Santos, M.D.,
conducted a study to determine how often PillCam SB identifies significant
findings in inflammatory bowel disease (IBD) patients and whether those
findings impacted the management of these patients. Sixty-nine (69)
patients were grouped into one of three categories based on their
indication for capsule endoscopy: Indeterminate colitis to rule out small
bowel disease (IC), known Crohn's disease with unexplained symptoms (CD-Sx)
or known Crohn's disease with obscure bleeding (CD-OB). The investigators
concluded that PillCam SB findings and the associated changes in management
were significantly more common in patients with known Crohn's disease with
unexplained symptoms, or obscure bleeding, than in patients with
indeterminate colitis. Overall PillCam SB led to a change in management in
the majority of patients 59% (n=41), supporting its use in patients with
IBD.
"Development and Validation of a Capsule Endoscopy Scoring Index for Small
Bowel Mucosal Disease Activity: The Lewis Score" (Poster #689) - Monday,
October 23rd 12:15pm - 2:15pm PDT
A team of seven investigators sought to develop and validate a simple,
user-friendly PillCam capsule endoscopy scoring index to measure small
bowel mucosal disease activity. Over a two year period, seven endoscopic
variables were developed and evaluated including erythema; edema;
nodularity, villous appearance; denuded mucosa, ulceration and stenosis.
Additional index parameters measured include the number of lesions, the
longitudinal extent of the disease, and ulcer shape and size. Based on a
prospective review of forty (40) full length PillCam SB videos and ten (10)
thumbnailed studies, the investigators concluded that the scoring index
should include three variables; villous edema, ulceration and stenosis. The
study also concluded that The Lewis Capsule Endoscopy scoring index may
prove useful in measuring small bowel mucosal disease activity and serve as
an objective scoring metric to measure small bowel disease states.
About PillCam COLON
PillCam COLON is the third video capsule to be developed and manufactured
by Given Imaging Ltd. The Company expects to file for clearance of PiIlCam
COLON with the U.S. Food and Drug Administration by the end of 2006. The
capsule measures 11 mm by 31 mm -- roughly the size of a large vitamin
pill. Since the lumen of the colon is wider than the small bowel and it is
highly compartmentalized, the Company has integrated new features into
PillCam COLON. The capsule has tiny cameras at each end which capture 4
images a second for up to 10 hours. Each camera contains automatic lighting
control and captures more than twice the coverage area and depth of field
of the PillCam™ SB capsule that is used to diagnose diseases in the
small intestine. Pivotal multi-center trials are underway in Europe and the
U.S.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and marketing innovative, patient-friendly products for detecting
gastrointestinal disorders. The company's technology platform is the
PillCam™ Platform, featuring the PillCam video capsule, a disposable,
miniature video camera contained in a capsule, which is ingested by the
patient, a sensor array, data recorder and RAPID® software. Given
Imaging has three commercially available capsules: the PillCam SB video
capsule to visualize the entire small intestine which is currently marketed
in the United States and in more than 50 other countries; the PillCam ESO
video capsule to visualize the esophagus; and the Agile™ patency capsule
to determine the free passage of the PillCam capsule in the GI tract. The
PillCam COLON video capsule to visualize the colon has been cleared for
marketing in the European Union and multi-center clinical trials are
underway in Europe and the U.S. A capsule to visualize the stomach is under
development. More than 400,000 patients worldwide have benefited from the
PillCam capsule endoscopy procedure. Given Imaging's headquarters,
manufacturing and R&D facilities are located in Yoqneam, Israel; it has
direct sales and marketing operations in the United States, Germany and
France, and local offices in Japan, Spain and Australia. For more
information, visit http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning
of the "safe harbor" provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These forward-looking statements include, but are not
limited to, projections about our business and our future revenues,
expenses and profitability. Forward-looking statements may be, but are not
necessarily, identified by the use of forward-looking terminology such as
"may," "anticipates," "estimates," "expects," "intends," "plans,"
"believes," and words and terms of similar substance. Forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual events, results, performance, circumstances or
achievements of the Company to be materially different from any future
events, results, performance, circumstances or achievements expressed or
implied by such forward-looking statements. Factors that could cause
actual events, results, performance, circumstances or achievements to
differ from such forward-looking statements include, but are not limited
to, the following: (1) satisfactory results of clinical trials with PillCam
Colon, (2) changes in regulatory environment, (3) our success in
implementing our sales, marketing and manufacturing plans, (4) protection
and validity of patents and other intellectual property rights, (5) the
impact of currency exchange rates, (6) the effect of competition by other
companies, (7) the outcome of future litigation, including patent
litigation with Olympus Corporation, (8) the reimbursement policies for our
product from healthcare payors, (9) quarterly variations in operating
results, (10) the impact of the newly adopted SFAS 123R for expensing
option-based payments, (11) the possibility of armed conflict or civil or
military unrest in Israel, and (12) other risks and factors disclosed in
our filings with the U.S. Securities and Exchange Commission, including,
but not limited to, risks and factors identified under such headings as
"Risk Factors," "Cautionary Language Regarding Forward-Looking Statements"
and "Operating Results and Financial Review and Prospects" in the Company's
Annual Report on Form 20-F for the year ended December 31, 2005. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date of this press release. Except for the
Company's ongoing obligations to disclose material information under the
applicable securities laws, it undertakes no obligation to release publicly
any revisions to any forward-looking statements, to report events or to
report the occurrence of unanticipated events.